HALCION 125 MICROGRAMS Coated tablet

Зміст інструкції

1. HALCION 125 microgram tablets, 250 microgram tablets
   1. What is Halcion and what is it used for
   2. What you need to know before you take Halcion
   3. How to take Halcion
   4. Possible side effects
   5. How to store Halcion
   6. Contents of the pack and other information

HALCION 125 microgram tablets, 250 microgram tablets

Triazolam

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Halcion is and what it is used for
• 2. What you need to know before you take Halcion
• 3. How to take Halcion
• 4. Possible side effects
• 5. How to store Halcion
• 6. Contents of the pack and other information

1. What is Halcion and what is it used for

Halcion contains the active ingredient triazolam. Triazolam belongs to a group of medicines called
benzodiazepines, used to treat sleep disorders (insomnia) only when they are severe, disabling or
cause significant discomfort.
Halcion is used for the short-term treatment of insomnia, when the disorder is severe and causes
discomfort in normal daily life.

2. What you need to know before you take Halcion

Do not take Halcion:

• if you are allergicto triazolam, to benzodiazepines or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from myasthenia gravis, a disease that causes severe muscle weakness;
• if you have severebreathing problems;
• if you suffer from sleep apnea, i.e. pauses in breathing during sleep;
• if you have severeliver problems;
• if you are taking the following medications simultaneously:
• medicines against fungal infections containing ketoconazoleor itraconazole,
• medicines against depression containing nefazodone,
• medicines against HIV infection containing efavirenzor HIV protease inhibitors (e.g. ritonavir),
• or other medicines that strongly reduce the activity of some liver enzymes (see section “Other medicines and Halcion”).

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Halcion.
Take this medicine with caution if:

• you are elderlyand/or frail. The doctor will prescribe a reduced dose of this medicine;
• you have liver problemsof mild or moderate severity;
• you have breathing problems, because this medicine may worsen your condition;
• you have or have had problems with alcohol or drug abusein the past, because there is a greater risk of developing a dependence on Halcion (see “Development of dependence”);
• you are taking other medicines that cause drowsiness or act on the brain and mind (see section “Other medicines and Halcion”);
• you suffer from depression. Halcion, like other benzodiazepines, should not be used alone to treat depression or anxiety associated with depression because it may worsen the tendency to suicide;
• you suffer from psychosis, a mental illness that alters behavior and causes difficulty relating to other people. Halcion is not recommended as the primary treatment for this condition.

Because triazolam can cause sedation (drowsiness, sleepiness, dizziness, loss of coordination and/or
difficulty coordinating movements), patients, especially the elderly, are at increased risk of falls.
Memory disorders
You may have difficulty remembering what happened aftertaking Halcion, especially if
you haven't slept enough (about 7-8 hours).
Paradoxical reactions
Halcion can cause effects opposite to those expected ( paradoxical effects) (see section 4 “Possible
side effects”). These effects are more common in children and the elderly.
If you experience these effects, see your doctor because treatment with Halcion should be discontinued.
Development of tolerance and dependence, withdrawal reactions and drug abuse
A reduction in effectiveness (tolerance) of this medicine may occur after continuous use.
This medicine is recommended for short-term treatment.
Treatment with this medicine also increases sensitivity to the effects of alcohol and other medicines
that affect brain function. Therefore, talk to your doctor if you are using alcohol or medicines of
this type.
The use of benzodiazepines, including Halcion, can lead to dependence. The risk of dependence increases with
higher doses and continuous use. The risk of dependence also increases if you have a history of alcohol or
drug abuse and in patients with significant personality disorders.
See your doctor if

• you have taken or are currently taking illegal substances
• you regularly consume alcohol or have frequently consumed large amounts of alcohol in the past
• you have had or currently have a desire to take large amounts of medicines.

In principle, benzodiazepines should only be used for short periods and discontinued
gradually. Before starting treatment, you and your doctor should agree on how long
to take the medicine.
If you suddenly stop taking the medicine or rapidly reduce the dosage, withdrawal reactions may occur. Do not suddenly stop this medicine. Ask your doctor for advice on
how to stop treatment.
Some withdrawal reactions can be life-threatening.
Withdrawal reactions can range from mild depressed mood, insomnia and headache to a
more severe syndrome with muscle pain, muscle cramps and abdominal pain, vomiting, sweating, tremors,
seizures, anxiety, tension, restlessness, confusion and irritability. More serious signs and symptoms of withdrawal,
including life-threatening reactions, can include: feeling detached or alienated from oneself and
from the outside world, excessive perception of noise, numbness and tingling in the extremities, increased
sensitivity to light, noise and physical contact, hallucinations, delirium tremens, depression, mania,
psychosis, seizures and suicidal ideation.
The symptoms for which this medicine was prescribed may also reappear for a short
period (rebound phenomena). Do not give Halcion to family members or friends. Keep this medicine safely
so that it cannot cause harm to others.

Children and adolescents
The efficacy and safety of Halcion in children and adolescents under 18 years of age are not known.
The doctor will decide whether Halcion can be given to children and adolescents based on their
conditions.

Other medicines and Halcion
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The concomitant use of Halcion and opioids (strong painkillers, medicines for substitution therapy and some
cough medicines) increases the risk of drowsiness, difficulty breathing (respiratory depression), coma
and can be life-threatening.
For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if the doctor prescribes Halcion together with opioids, the dose and duration of concomitant therapy
must be limited by your doctor.
Tell your doctor about all opioid medicines you are taking and carefully follow
your doctor's recommendations on dosage. It may be helpful to inform friends or relatives to make them
aware of the above signs and symptoms. Contact your doctor if these
symptoms occur.
Halcion can change the effect of other medicines and other medicines can change the effect of Halcion.
The following medicines must notbe taken together with Halcion (see also section “Do not take
Halcion”):

• ketoconazole, itraconazole(medicines against fungal infections);
• nefazodone(medicine against depression);
• efavirenzand other medicines used to fight HIV infection (e.g. ritonavir);
• other medicines that strongly reduce the activity of some liver enzymes.

Tell your doctor if you are taking any of the following medicines together with Halcion because caution is necessary:

• other medicines against fungal infections. Their administration together with Halcion is not recommended;
• cimetidine, a medicine used to reduce stomach acidity;
• erythromycin, clarithromycin, troleandomycin, isoniazidand rifampicin(antibiotics);
• diltiazemand verapamil(medicines against high blood pressure);
• oral contraceptives;
• imatinib, medicine against some types of tumors;
• aprepitant, medicine against nausea and vomiting;
• medicinesthat act on the brainand mind, such as:
• antipsychotics, medicines for the treatment of some mental illnesses
• hypnotics, sedatives, calmants and sleep inducers
• anxiolytics, medicines for the treatment of anxiety
• antidepressants(e.g. fluvoxamine, sertraline and paroxetine), medicines for the treatment of depression
• narcotic analgesics, medicines for the treatment of severe pain which, when administered together with Halcion, can cause euphoria, with an increased likelihood of developing dependence
• antiepileptics(e.g. carbamazepine), medicines for the treatment of seizures
• anesthetics, medicines that induce anesthesia, i.e. reversible loss of sensation
• sedative antihistamines, medicines to counter allergic reactions.

Halcion with drinks and alcohol
It is notrecommended to drink alcoholand grapefruit juicewhile taking Halcion because the effects of
this medicine may be increased.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Pregnancy
The use of Halcion during pregnancy can cause harm to the fetus.
If you take this medicine during the last 3 months of pregnancy, or during labor, the
baby may present with poor muscle tone (floppy baby syndrome) and withdrawal symptoms (see section 3 “If you stop taking Halcion”).
Breastfeeding
Halcion should not be used by breastfeeding mothers because this medicine can pass into
breast milk.

Driving and using machines
Halcion can significantly affect your ability to drive and use machines.

Do notdrive or use machines if you experience drowsiness or dizziness during treatment with Halcion.
Halcion can also cause a condition called “ sleep driving”, i.e. you may not
be fully awake while driving and not remember having driven. These effects may be
increased if you haven't slept enough or if you have consumed alcoholic beverages.

Halcion contains lactose, sodium and sodium benzoate (E211)
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some sugars, ask
him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
This medicine contains 0.15 mg of sodium benzoate (E 211) per tablet. Sodium benzoate can
increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

3. How to take Halcion

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The dose and duration of administration must be adapted to your individual condition. The doctor
will advise you on the dose and the number of daily administrations and the duration of treatment with Halcion, so
that you take the lowest possible dose for the shortest possible time. Do not modify or exceed the
prescribed dose. To stop treatment, the dose must be reduced gradually in consultation
with your doctor. This reduces the risk of withdrawal reactions, which in some cases may be
life-threatening (see paragraph 2).

Adults
The recommended dose is 1 tablet (125 micrograms or 250 micrograms) to be taken once a
day just beforegoing to bed.
The doctor will advise you on the lowest possible dose.
It is recommended not to exceed the maximum daily dose.

If you are elderly and/or suffer from liver or kidney problems
The recommended dose is 1 tablet of 125 micrograms to be taken once a day just before
going to bed.

Duration of treatment
Halcion should be taken for short periods of time. The maximum recommended duration of therapy should not
exceed 4 weeks. This period also includes the time required to gradually reduce the
dose of Halcion until discontinuation. The doctor will decide based on your condition whether you can take
this medicine for a longer period.

If you take more Halcion than you should
If you have taken an excessive dose of Halcion, contact your doctor immediately or go to the nearest emergency
room. Symptoms may include:

• difficulty speaking;
• drowsiness;
• loss of coordination;
• breathing problems;
• coma.

If you forget to take Halcion
If you forget to take a dose, take it as soon as you remember, but make sure you can rest immediately
afterwards and for long enough. Do not take a double dose to make up for a missed dose.

If you stop taking Halcion
Donot suddenly stop taking Halcion unless you experience serious
allergic reactions (see paragraph 4 “Possible side effects”). Always consult your doctor before
stopping taking Halcion. You must reduce the doses gradually to avoid experiencing:

• withdrawal symptomssuch as:
• severe symptoms: feeling detached from oneself or from the outside world, numbness and tingling in the legs or arms, increased sensitivity to light, sounds and physical contact, hallucinations, seizures;
• other symptoms: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability;
• rebound insomnia. You may temporarily develop insomnia that is worse than what you had before starting treatment with this medicine.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

STOPtaking this medicine immediately and contact your doctor if you experience any of the
following side effects because they are serious:

• severe allergic reaction(anaphylactic shock, anaphylactoid reactions)
• swelling of the face, tongue and throat with resulting inability to swallow and breathe (angioedema)

Contact your doctor immediatelyif you experience any of the following side effects because the use of
Halcion must be stopped:

• opposite effects to those expected (paradoxical effects) (see section 2 “Paradoxical reactions”) such as:
• aggression
• hallucinations
• restlessness
• agitation
• irritability
• delusion
• anger
• nightmares
• thought disorders
• behavioural disorders

Contact your doctor immediatelyif you experience any of the following side effects because they can be

serious:

• depressionor unmasking of existing depression drug abuse, drug dependence(see section 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• withdrawal symptoms(withdrawal syndrome) and rebound symptoms(see section 2 “Development of tolerance and dependence, withdrawal reactions and drug abuse”)
• “drowsiness while driving”, a sleep-related behaviour disorder (see section 2 “Driving and operating machinery”)
• difficulty rememberingwhat happened after taking the medicine (see section 2 “Memory disorders”)
• reduced breathing

Contact your doctor if you experience any of the following side effects:

Common side effects(may affect up to 1 in 10 people):

• drowsiness
• dizziness
• headache
• loss of coordination

Uncommon side effects(may affect up to 1 in 100 people):

• confusion
• insomnia
• memory loss
• vision disorders

Rare side effects(may affect up to 1 in 1,000 people):

• skin rash
• severe muscle weakness

Not known(frequency cannot be estimated from available data):

• allergic reactions, swelling due to allergy, hypersensitivity
• sleepwalking
• fainting
• sedation, reduced level of consciousness
• difficulty speaking
• loss of attention
• alterations in taste
• alterations in sexual drive
• falling down

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Halcion

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Halcion contains
The active ingredient is triazolam.
Each Halcion 125 microgram tablet contains 125 micrograms of triazolam.
The other ingredients are: lactose, microcrystalline cellulose, colloidal silicon dioxide, dioctyl sodium sulfosuccinate,
sodium benzoate (E 211), corn starch, magnesium stearate, indigotine (E132) aluminium lake, erythrosine
(E127) aluminium lake.
(see section 2 “Halcion contains lactose, sodium and sodium benzoate (E211)”
Each Halcion 250 microgram tablet contains 250 micrograms of triazolam.
The other ingredients are: lactose, microcrystalline cellulose, colloidal silicon dioxide, dioctyl sodium sulfosuccinate,
sodium benzoate (E 211), corn starch, magnesium stearate, indigotine (E132) aluminium lake.
(see section 2 “Halcion contains lactose, sodium and sodium benzoate (E211)”

Description of the appearance of Halcion and contents of the pack
Halcion 125 microgram tablets are lavender-coloured tablets. The tablets are
available in PVC/Aluminium blisters in packs of 10 and 20 tablets.
Halcion 250 microgram tablets are light blue-coloured tablets. The tablets are
available in PVC/Aluminium blisters in packs of 10 and 20 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)